FDA Orange Book · active-ingredient family
Hydrochlorothiazide; triamterene
Hydrochlorothiazide; triamterene is approved as 2 brand and 23 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DYAZIDE · NDA 016042
2
Brand (NDA)
23
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DYAZIDERLD×2 | GLAXOSMITHKLINE LLC | NDA 016042 | — | Mar 03, 1994 | |
| MAXZIDERLD×2 | AUROBINDO PHARMA USA | NDA 019129 | AB | Oct 22, 1984 |
Generic (ANDA) products (23)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | MACLEODS PHARMS LTD | ANDA 214611 | — | Jan 28, 2025 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE×2 | RUBICON RESEARCH | ANDA 216211 | AB | Feb 23, 2022 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | CADILA | ANDA 208358 | AB | Feb 11, 2019 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE×2 | ZYDUS PHARMS | ANDA 208360 | AB | Jun 29, 2018 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | LANNETT CO INC | ANDA 201407 | AB | Dec 09, 2011 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | DURAMED PHARMS BARR | ANDA 075052 | — | Jun 18, 1999 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE×2 | APOTEX INC | ANDA 071251 | AB | May 05, 1998 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | ANI PHARMS | ANDA 074970 | — | Jan 06, 1998 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | NOVARTIS | ANDA 074857 | — | Sep 09, 1997 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | SANDOZ | ANDA 074821 | AB | Jun 05, 1997 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | PHARMOBEDIENT | ANDA 074701 | — | Jun 07, 1996 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | PLIVA | ANDA 074026 | — | Apr 26, 1996 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | ANI PHARMS | ANDA 073467 | — | Jan 31, 1996 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | ANI PHARMS | ANDA 074259 | — | Mar 30, 1995 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | WATSON LABS | ANDA 073449 | AB | Sep 23, 1993 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | SANDOZ | ANDA 073281 | AB | Apr 30, 1992 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | CHARTWELL RX | ANDA 073191 | — | Jul 31, 1991 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | WATSON LABS | ANDA 071851 | AB | Nov 30, 1988 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | CHARTWELL RX | ANDA 072011 | AB | Jun 17, 1988 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | AM THERAP | ANDA 072022 | — | Apr 17, 1988 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | QUANTUM PHARMICS | ANDA 071980 | — | Apr 17, 1988 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | WATSON LABS | ANDA 071969 | — | Apr 17, 1988 | |
| TRIAMTERENE AND HYDROCHLOROTHIAZIDE | VITARINE | ANDA 071737 | — | Feb 12, 1988 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Hydrochlorothiazide; triamterene — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
